Search Results
Found 2 results
510(k) Data Aggregation
K Number
K150248Device Name
ORL Video NasoPharyngo-Larngoscope
Manufacturer
JEDMED INSTRUMENT COMPANY
Date Cleared
2015-07-23
(170 days)
Product Code
EQN
Regulation Number
874.4760Why did this record match?
Product Code :
EQN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Jedmed ORL Video Nasopharyngo-Laryngoscopes are intended to examine the larynx, nasal cavity and nasal pharynx. They are used between the upper respiratory tracts of the nasal passage and vocal cords.
Device Description
This flexible scope is designed with the insertion tube with its bendable distal tip w/camera, the handle, the umbilical unit which has the leakage tester, and connection for light source port and power/video port The handle incorporates the control lever to bend the distal tip.
Ask a Question
K Number
K132039Device Name
ERGO-FLEX LARYNGO-NASOPHARYNGOSCOPE EF-N AND EF-N SLIM
Manufacturer
JEDMED INSTRUMENT CO.
Date Cleared
2014-02-21
(234 days)
Product Code
EQN
Regulation Number
874.4760Why did this record match?
Product Code :
EQN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
JEDMED's Ergo-Flex EF-N and EF-N Slim Laryngo-Nasopharyngoscopes are intended to examine the larynx, nasal cavity and nasal pharynx. They are used between the upper respiratory tracts of the nasal passage and the vocal cords.
Device Description
This flexible scope is designed with the insertion tube with its bendable distal tip, the handle, the eyepiece and the focus ring. The handle incorporates the control lever to bend the distal tip and the connectors for the leakage tester and the fiber optic light-guide cable.
Ask a Question
Page 1 of 1